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510(k) Data Aggregation
(29 days)
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin-coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.
The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.
Here's a breakdown of the acceptance criteria and the study information for the NOVEOS Specific IgE (sIgE) Assay, Capture Reagent M006, Alternaria alternata, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Specific Value/Target) | Reported Device Performance (Value/Range) | Comments |
|---|---|---|---|
| Clinical Performance | Positive Agreement (vs. predicate ImmunoCAP) | 91.7% (95% CI: 84.9% to 95.6%) | Met |
| Negative Agreement (vs. predicate ImmunoCAP) | 98.0% (95% CI: 94.2% to 99.3%) | Met | |
| Clinical Sensitivity (vs. clinical diagnosis) | 64.6% (95% CI 52.5% to 75.1%) | Met | |
| Clinical Specificity (vs. clinical diagnosis) | 99.1% (95% CI 95.3% to 99.8%) | Met | |
| Precision/Reproducibility | Total CV for LoQ15 | 11.3% | Met (Individual CV values vary by sample and type of imprecision, but the reported values indicate acceptable precision). |
| Total CV for LoQ33 | 7.0% | Met | |
| Total CV for NOVEOS Pos Sample | 11.7% | Met | |
| Total CV for Lyphochek Pos Sample | 8.9% | Met | |
| Total CV for PP46 | 7.9% | Met | |
| Total CV for PP28 | 7.4% | Met | |
| Lot-to-Lot Imprecision | Total CV for LoQ15 | 10.8% | Met |
| Total CV for LoQ33 | 7.9% | Met | |
| Total CV for NOVEOS Pos Sample | 11.6% | Met | |
| Total CV for Lyphochek Pos Sample | 8.9% | Met | |
| Total CV for PP46 | 8.5% | Met | |
| Total CV for PP28 | 7.8% | Met | |
| Site-to-Site Reproducibility | Total CV for NOV | 5.4% | Met |
| Total CV for PP74 | 10.9% | Met | |
| Total CV for PP75 | 10.1% | Met | |
| Total CV for PP76 | 10.1% | Met | |
| Total CV for PP77 | 14.0% | Met | |
| Linearity | R² value | 1.000 | Met (Indicating excellent linearity) |
| Slope (95% CI) | 0.99 to 1.01 | Met (Close to 1.00) | |
| Intercept (95% CI) | -0.16 to 0.07 | Met (Close to 0) | |
| Detection Limits | LoB | 0.03 kU/L | Met |
| LoD | 0.04 kU/L | Met | |
| LoQ (claimed) | 0.17 kU/L | Determined to be 0.12 kU/L, so the claimed 0.17 kU/L is met. | |
| Reference Range | Expected value for non-atopic person | Negative ( |
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